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FEATURED EDITORIAL

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The Hidden Engineering Behind Successful Upstream Bioprocessing

In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.

GUEST COLUMNISTS

What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.
Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.
Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
Active Versus Passive Shipping Solutions For Clinical Shipments
Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.
The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

PHARMA OUTSOURCING WHITE PAPERS

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics
Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

Nose To Brain (N2B) Drug Delivery – Benefits And Challenges
Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).
Immunogenicity Risk Assessment In Drug Candidate Selection
Identify and address potential anti-drug immune responses early in development to streamline your drug’s path to clinical success—start smart and finish fast.
In Vivo Testing Of Nasal Dosage Forms
Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.
Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
EMA Support For Rare Disease Therapies
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.